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We work with equipment and software
vendors providing solutions and products to the FDA
regulated industries. We provide wide range of
services to meet the specific needs of the vendors catering
to the GxP companies.
Value Proposition..
What vendor services do we provide?
Develop a validation and compliance suite (Requirements &
Specifications,
Manuals, SOPs, Training Documents, Validation
Protocols, Configuration Best
Practices) specific to the implementation of
your product.
Read more..
Develop custom validation packages for your clients in an
expedient and cost
effective manner.
Support your client’s onsite protocol executions at a very
reasonable price
Provide consulting services to marketing and application
development groups
for developing 21 CFR Part 11 compliant
software products. These may include:
- Develop Part 11
Requirement Specifications
- Provide Software Technical
Support
- Develop Software Modules
- Certify Final Versions for
Part 11 Compliance.
Develop white papers to demonstrate Part 11 compliance.

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